Module 9 2021

CLINICAL DEVELOPMENT

Biologics

ATMPs

Large, blind, randomized pivotal trial

Unblind (non-randomized) pivotal trial

Standard design

Adaptative design

FIH  Ph I  Ph II  Ph III  MA

FIH  (Ph I/II  (Ph III))  MA

Healthy volunteers for FIH

Patient enrollment

Conditional , Exception MA

Full MA

PASES , Registry establishment

Novartis Pharma AG- Business use only- not for further distribution

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